Encorafenib (3) – Braftovi®

• Clinical trials
  • The PHAROS Phase II trial – which is currently ongoing, open-label, multicentre and single-arm – enrolled patients with metastatic NSCLC harbouring a BRAF V600 mutation – 59 patients in the first-line setting and 39 previously treated patients.

a) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and a BRAF V600E mutation; first-line treatment

• The additional benefit is not proven.
• As the single-arm PHAROS trial does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.

b) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% and a BRAF V600E mutation; first-line treatment

• The additional benefit is not proven.
• As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.

c) Adults with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation; following first-line treatment

• The additional benefit is not proven.
• As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.

• Conclusion
  • Consequently, the G-BA concludes that an additional benefit is not proven for encorafenib in combination with binimetinib in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring a BRAF V600E mutation.

Courtesy translation only, please refer to the German original.